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Recruiting NCT06923202

Study of Alloknesia in Atopic Dermatitis

— Observational Atopic Dermatosis Alloknesie

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Atopic Dermatosis, Alloknesie. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Alloknesia is defined as pruritus (= itching) triggered by light mechanical stimuli, which are responsible for the perception of light touch under physiological conditions, but which are perceived as pruritic under pathological conditions. Alloknesia occurs mainly in the context of chronic pruritus. Consequently, patients suffering from chronic pruritus frequently perceive light touch sensations as pruritic, which can be particularly unpleasant and alter human interactions and quality of life on a daily basis. However, the epidemiology and burden of alloknesia have never been studied, whatever the cause of chronic pruritus.Atopic dermatitis is one of the main diseases causing chronic itching, and patients frequently complain of alloknesia. In this study, the investigators are studying the frequency of alloknesia in patients with atopic dermatitis and measuring the consequences of alloknesia in these patients.

Primary outcome measures

  • Alloknesia diagnostic questionnaire [Time frame: At enrollment. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.]
Secondary outcome measures (8)
  • WI-NRS scale / Worst Itch Numeric Rating Scale [Time frame: At enrollment. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.]
  • ItchyQoL questionnaire / quality-of life instrument for pruritus [Time frame: At enrollment. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.]
  • DLQI questionnaire / Dermatology Life Quality Index [Time frame: At enrollment. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.]
  • HADS questionnaire / Hospital Anxiety and Depression Scale [Time frame: At enrollment. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.]
  • PUSH-D questionnaire / Patient Unique Stigmatization Holistic tool in dermatology [Time frame: At enrollment. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.]
  • Stress perçu : PSS / Perceived Stress Scale [Time frame: At enrollment. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.]
  • Epworth questionnaire / sleepiness scale [Time frame: At enrollment. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.]
  • ISS questionnaire / Sexual Satisfaction Index [Time frame: At enrollment. If the patient completes the questionnaires at home, they will be brought back by the patient at their next medical consultation.]

Eligibility criteria

Inclusion criteria

  • Age ≥18 years
  • No opposition from the patient
  • Diagnosis of atopic dermatitis more than 6 months old

Exclusion criteria

  • Patients who are physically or mentally unable to complete the questionnaires.
  • Patients on systemic treatment for 1 month or more
  • Refusal to participate
  • Patients under legal protection (guardianship, curatorship)
  • Patients under court protection

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

France · 8 centers
  • CHU d'Angers — Angers
  • CHU de Brest — Brest
  • CHD Vendée — La Roche-sur-Yon
  • Groupe Hospitalier Bretagne Sud — Lorient
  • CHU de Nantes Hôtel-Dieu — Nantes
  • CHU de Rennes — Rennes
  • CHU de Tours — Tours
  • CH Bretagne Atlantique — Vannes

Publications

  • Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540. PMID 1798888
  • Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x. PMID 8033378
  • Kimel M, Zeidler C, Kwon P, Revicki D, Stander S. Validation of Psychometric Properties of the Itch Numeric Rating Scale for Pruritus Associated With Prurigo Nodularis: A Secondary Analysis of a Randomized Clinical Trial. JAMA Dermatol. 2020 Dec 1;156(12):1354-1358. doi: 10.1001/jamadermatol.2020.3071. PMID 32936233

Identifiers

NCT: NCT06923202 · 29BRC24.0355

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗